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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K961481
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cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers:... 2 03/28/2018 Roche Diagnostics Corporation
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001... 2 02/01/2018 Roche Diagnostics Corporation
cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 i... 2 10/25/2016 Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter ... 2 06/14/2014 Roche Diagnostics Operations, Inc.
Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vit... 2 03/16/2012 Roche Diagnostics Operations, Inc.
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642... 2 10/22/2008 Roche Diagnostics Corp.
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers ... 2 08/13/2008 Roche Diagnostics Corp.
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